Bite block covers
by Snowdent Healthcare Co., Ltd 6 variants
Ref 145Model BC01、BC02、BC03、BC04、009S、009M、 009L、145、BC05-3D、BC06-3D、Customized
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697999994sleeve431BB 06979999944357 | Date24 Apr 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Barrier Sleeves/Covers/Film
- Model / Reference
- BC01、BC02、BC03、BC04、009S、009M、 009L、145、BC05-3D、BC06-3D、Customized, 145
- Primary DI / UDI-DI
- 06979999944357
- Basic UDI-DI
- 697999994sleeve431BB
- EMDN Code
- Q010599 Dental instruments, single-use - other
- Device Class
- Class I
- Market of Registration
- Hungary
Manufacturer details
- EUDAMED SRN
- CN-MF-000008775
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Snowdent Healthcare Co., Ltd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No